study to determine the efficacy and safety of els-m11 in acute migraine

Conditions: Migraine Headaches

Summary: this is a phase 1/ phase 2, 12-week, multi-center, randomized, double-blind, cross-over, placebo-controlled study to evaluate the efficacy and safety of els-m11 compared to placebo in 50 male and female subjects, aged 18 to 65 years that suffer recurring moderate-severe migraine headaches (2-8 per month). this study is designed to describe the efficacy and safety of els-m11 as compared to placebo.

achelios is developing els-m11 for topical application for the acute treatment of migraine events in patients with a history of migraine with or without aura. to be eligible for the study, patients must have a one-year documented history of migraine headache (as defined by the international headache society ihs), with or without aura, with 2≤8 moderate or severe migraine attacks per month in the 2 months prior to the screening visit. the total duration of the study is the completion of five migraine headaches per subject over a maximum 12 week period followed by a 3-14 day follow-up period.

Eligibility criteria:
inclusion criteria: * provide written informed consent * males and females aged 18-65 who can read, write and understand english * subject has at least a one year documented history of migraine headache (defined by international headache society ihs) migraine definitions, with or without aura, with 2≤8 moderate or severe migraine attacks per month in the 2 months prior to the screening visit * is stable on the current standard non-opioid rescue medication for at least 2 months prior to randomization * can distinguish migraine from tension headache (ha), with 24 hours of freedom from ha between migraine events * women of childbearing potential must be currently using or willing to use contraception (30 days prior to start of study medication and for 21 days after taking study medication) * women of non-childbearing potential include females regardless of age, with functioning ovaries and who have a current documented tubal ligation \[hatcher, 2004\] bilateral oophorectomy or total hysterectomy, or post-menopausal females * the subject is able and willing to perform the assessments and procedures as specified in this protocol, including the ability to learn and follow instructions for epro device exclusion criteria: * migraineurs taking opioid-based rescue medications for any indication * subject has history of mild migraine events or migraines that usually resolve spontaneously in less than 2 hours * subject has menstrual migraines * positive drug test * subject has basilar or hemiplegic migraines * subject has more than 15 headache-days per month * subjects with a history of facial allodynia * subject has a history of vomiting during more than 30% of migraine episodes * self confinement to bed rest for more than 50% of migraine episodes * subject was greater than 50 years old at age of migraine onset * acute coronary syndrome (i.e., myocardial infarction and unstable angina), stroke or resuscitated cardiac arrest within the past 3 months * severe congestive heart failure * systolic blood pressure (sbp) \>160 mmhg or diastolic blood pressure (dbp) \>100 mmhg measured in the sitting position at visit 1 * current active renal disease * any history of pyelonephritis * evidence of active liver disease * alanine aminotransferase (alt), aspartate aminotransferase (ast) or alkaline phosphatase \>2 times the upper limit of the reference range (ulrr), or total bilirubin \>1.5 times the ulrr at visit 1 * past history of acute pancreatitis with current triglycerides 4.56 mmol/l (400 mg/dl) at visit 1 * history of malignancy within the past 3 years, other than non-melanoma skin cancer (i.e., basal or superficial squamous cell carcinoma) and treated cervical cancer in-situ * any planned major surgery to be performed during the study (e.g., coronary artery bypass surgery, abdominal aortic aneurysm repair, etc.) * current life-threatening condition * significant hypersensitivity to nsaids (e.g., difficulty swallowing or breathing, tachycardia, anaphylaxis, angioedema or skin reaction) * pregnancy (defined by positive urine pregnancy test) or lactation at visit 1, or planning to become pregnant prior to completion of the study * history or suspicion of alcohol or substance abuse (current or past 6 months). * participation in any clinical trial within 30 days prior to visit 1 * subjects with a history of hypersensitivity to products containing tiaprofenic acid, suprofen, fenofibrate, oxybenzone, or octocrylene (e.g., sunscreen, perfume) * subjects with a history of photosensitivity * any clinically significant abnormality or any reason that the subject may not be able to complete the full study observational period

Keywords: migraine headache photophobia phonophobia aura topical treatment